MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752520
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during the surgical procedure, it was identified that the 4.8 fr double j catheter had visible structural damage.The procedure was completed with another of the same device and the patient condition after the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the returned percuflex pluswas analyzed, and a visual evaluation noted that the bladder coil had become detached, evidence of "stent coil detached/separated".Upon inspection under magnification, it was observed that the suture hole was torn up to the tip, suggesting that the suture may have been removed with excessive force, which is evidenced by the condition described as "suture hole torn".Nevertheless, there was no detachment noted at the stent shaft, thus preventing confirmation of the reported event of "stent shaft break".The event labeled as "stent shaft break" will be assigned under the analysis cause code of "no problem detected".The retrieval line may be removed prior to placement at the discretion of the physician.Should the retrieval line become entangled with the bladder coil and is subsequently removed with excessive force, it could lead to the detachment of the stent during the procedure, thereby impacting the device's performance.It is likely that the removal of the suture contributed to the detachment of the bladder coil and the tearing observed at the suture hole up to the tip.Based on the analysis results of observed stent coil detached/separated and suture hole torn, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.Correction to field block g2 (report source).
Event or Problem Description
It was reported that during the surgical procedure, it was identified that the 4.8 fr double j catheter had visible structural damage.The procedure was completed with another of the same device and the patient condition after the procedure was stable.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22303019
• Report Number: 2124215-2025-40233
• Device Sequence Number: 8091659
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: (01)08714729056805(17)271022(10)35120651
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0035120651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown